Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 1 of 49 PageID 68

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1 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 1 of 49 PageID 68 IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRECT OF FLORIDA TAMPA DIVISION, individually and as executor ) de son tort of the Estate of ), deceased, ) ) Plaintiff, ) v. ) Case No.: 8:15-cv VMC-EAJ ) JANSSEN RESEARCH & DEVELOPMENT, LLC ) JURY DEMANDED f/k/a JOHNSON AND JOHNSON ) PHARMACEUTICALS RESEARCH AND ) DEVELOPMENT LLC; JOHNSON & JOHNSON ) COMPANY; JANSSEN ORTHO, LLC; JANSSEN ) PHARMACEUTICALS, INC., f/k/a ORTHO- ) MCNEIL-JANSSEN PHARMACEUTICALS, INC.; ) BAYER CORPORATION; BAYER AG; BAYER ) HEALTHCARE LLC; BAYER HEALTHCARE ) PHARMACEUTICALS INC.; BAYER PHARMA ) AG; and BAYER HEALTHCARE AG, ) ) Defendants. ) / AMENDED COMPLAINT COMES NOW the Plaintiff tort of the Estate of, individually and as executor de son, deceased (hereinafter referred to as Plaintiff ), by and through her undersigned counsel, hereby submits this Amended Complaint against Defendants, JANSSEN RESEARCH & DEVELOPMENT, LLC f/k/a Johnson and Johnson Pharmaceuticals Research and Development LLC; JOHNSON & JOHNSON COMPANY; JANSSEN ORTHO, LLC; JANSSEN PHARMACEUTICALS, INC., f/k/a Ortho-McNeil- Janssen Pharmaceuticals, Inc.; BAYER CORPORATION; BAYER AG; BAYER HEALTHCARE LLC; BAYER HEALTHCARE PHARMACEUTICALS INC.; BAYER 1

2 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 2 of 49 PageID 69 PHARMA AG; and BAYER HEALTHCARE AG (hereinafter collectively referred to as Defendants ), for damages arising from the injuries of the Decedent, as a result of his exposure to the pharmaceutical product Xarelto, and upon information and belief, hereby alleges and states as follows: JURISDICTION AND VENUE 1. This Court has jurisdiction over this action pursuant to 28 U.S.C because the amount in controversy exceeds $75,000.00, exclusive of interest and costs, and because there is complete diversity of citizenship between the Plaintiff and the Defendants. 2. This Court has personal jurisdiction over the Defendants because they have done business in the State of Florida, have committed a tort in whole or in part in the State of Florida, have substantial and continuing contact with the State of Florida, and derive substantial revenue from goods used and consumed within the State of Florida. The Defendants actively advertise, promote, market, sell and distribute their pharmaceutical product, Xarelto, to physicians and consumers in the State of Florida on a regular and consistent basis. 3. Venue is proper in this jurisdiction pursuant to 28 U.S.C because a substantial part of the events or omissions giving rise to the claim occurred in this District, and because Defendants conduct substantial business in this District. TAG-ALONG ACTION 4. This is a potential tag-along action and in accordance with 28 U.S.C it should be transferred to the United States District Court for the Eastern District of Louisiana 2

3 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 3 of 49 PageID 70 for inclusion in In re Xarelto (Rivaroxaban) Products Liability Litigation, MDL # 2592 (Honorable Eldon E. Fallon). NATURE OF THE CASE 5. The Decedent,, used Xarelto which, as a direct result of the ingestion of Xarelto, ultimately caused and/or contributed to his death. 6. This action is brought by, individually and as executor de son tort of the Estate of. 7. At all times relevant and material hereto, Defendants were, and are, engaged in the business of designing, researching, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, disseminating and/or selling Xarelto within the State of Florida and throughout the United States. 8. When warning of safety and risks of Xarelto, Defendants negligently and inadequately represented to the general public, the medical and health care community, and specifically, the Decedent,, that Xarelto had been tested and was found to be safe and/or effective for its indicated use. 9. These negligent and inadequate representations were made by Defendants with the intent of inducing the general public and the medical and health care community to request, recommend, dispense and/or purchase Xarelto for use to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis and pulmonary embolism, to reduce the risk of recurrence of deep vein thrombosis and/or pulmonary embolism, and for prophylaxis of deep vein thrombosis for 3

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5 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 5 of 49 PageID Plaintiff, as executor de son tort of the Estate of has standing to bring this action under Florida law. 16. Plaintiff, in her individual capacity and as the spouse of the Decedent, has standing to bring this action. PARTY DEFENDANTS 17. Upon information and belief, Defendant JANSSEN RESEARCH & DEVELOPMENT, LLC f/k/a Johnson and Johnson Pharmaceuticals Research and Development LLC (hereinafter referred to as Janssen R&D ), is a limited liability company organized under the laws of New Jersey, with a principle place of business at One Johnson & Johnson Plaza, New Brunswick, New Jersey The member of Defendant Janssen R&D is. Accordingly, Defendant Janssen R&D is a citizen of New Jersey and Pennsylvania for purposes of determining diversity under 28 U.S.C Upon information and belief, Defendant Janssen R&D is the holder of the approved New Drug Application for Xarelto as well as its supplemental New Drug Application. 19. Upon information and belief, at all times relevant and material hereto, Defendant Janssen R&D was, and is, engaged in the business of designing, researching, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, disseminating and/or selling Xarelto within the State of Florida and throughout the United States. 5

6 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 6 of 49 PageID Upon information and belief, at all times relevant and material herein, Defendant Janssen R&D has, and does, transact and conduct substantial business in the state of Florida and throughout the United States, as set forth herein, and has, and does, derive substantial revenue from goods and products used in the State of Florida and within the United States. Upon information and belief, Defendant JOHNSON & JOHNSON COMPANY (hereinafter referred to as J&J ), is a New Jersey corporation with its principal place of business at One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, is a publically held corporation, and has no parent corporation. 21. Upon information and belief, at all times relevant and material hereto, Defendant J&J was, and is, engaged in the business of designing, researching, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, disseminating and/or selling Xarelto within the State of Florida and throughout the United States. 22. Upon information and belief, at all times relevant and material herein, Defendant J&J has, and does, transact and conduct substantial business in the state of Florida and throughout the United States, as set forth herein, and has, and does, derive substantial revenue from goods and products used in the State of Florida and within the United States. Upon information and belief, Defendant JANSSEN ORTHO, LLC (hereinafter referred to as Ortho ), is a Delaware limited liability company with a principle place of business at Stateroad 933 Km 0 1, Street Statero, Gaurabo, Puerto Rico The only member of Defendant Ortho is 6

7 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 7 of 49 PageID 74. Accordingly, Defendant Ortho is a citizen of Delaware, Ireland, and Puerto Rico for purposes of determining diversity under 28 U.S.C Upon information and belief, at all times relevant and material hereto, Defendant Ortho was, and is, engaged in the business of designing, researching, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, disseminating and/or selling Xarelto within the State of Florida and throughout the United States. 24. Upon information and belief, at all times relevant and material herein, Defendant Ortho has, and does, transact and conduct substantial business in the state of Florida and throughout the United States, as set forth herein, and has, and does, derive substantial revenue from goods and products used in the State of Florida and within the United States. Upon information and belief, Defendant JANSSEN PHARMACEUTICALS, INC., f/k/a Ortho-McNeil-Janssen Pharmaceuticals, Inc. (hereinafter referred to as Janssen Pharmaceuticals ), is a Pennsylvania corporation with its headquarters and principle place of business at 1125 Trenton-Harbourton Road, Titusville, New Jersey 08560, and is a whollyowned subsidiary of Defendant J&J. 25. Upon information and belief, at all times relevant and material hereto, Defendant Janssen Pharmaceuticals was, and is, engaged in the business of designing, researching, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, disseminating and/or selling Xarelto within the State of Florida and throughout the United States. 7

8 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 8 of 49 PageID Upon information and belief, at all times relevant and material herein, Defendant Janssen Pharmaceuticals has, and does, transact and conduct substantial business in the state of Florida and throughout the United States, as set forth herein, and has, and does, derive substantial revenue from goods and products used in the State of Florida and within the United States. 27. Upon information and belief, Defendant BAYER CORPORATION (hereinafter referred to as Bayer Corp. ), is an Indiana corporation with its principal place of business at 100 Bayer Road Pittsburgh, Pennsylvania Upon information and belief, at all times relevant and material hereto, Defendant Bayer Corp. was, and is, engaged in the business of designing, researching, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, disseminating and/or selling Xarelto within the State of Florida and throughout the United States. 29. Upon information and belief, at all times relevant and material herein, Defendant Bayer Corp. has, and does, transact and conduct substantial business in the state of Florida and throughout the United States, as set forth herein, and has, and does, derive substantial revenue from goods and products used in the State of Florida and within the United States. 30. Upon information and belief, Defendant BAYER AG (hereinafter referred to as Bayer ), is a foreign corporation domiciled in Germany with its principle place of business in Leverkusen, Germany. 8

9 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 9 of 49 PageID Upon information and belief, at all times relevant and material herein, Defendant Bayer licensed Xarelto for use within the State of Florida and throughout the United States. 32. Upon information and belief, at all times relevant and material hereto, Defendant Bayer was, and is, engaged in the business of designing, researching, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, disseminating and/or selling Xarelto within the State of Florida and throughout the United States. 33. Upon information and belief, at all times relevant and material herein, Defendant Bayer has, and does, transact and conduct substantial business in the state of Florida and throughout the United States, as set forth herein, and has derived substantial revenue from goods and products used in the State of Florida. 34. Upon information and belief, Defendant BAYER HEALTHCARE LLC (hereinafter referred to as Bayer HC ), is a Delaware limited liability company with its principle places of business located at 100 Bayer Road, Pittsburgh, Pennsylvania. Defendant Bayer HC s sole member is. Accordingly, Defendant Bayer HC is a citizen of Delaware, Pennsylvania and Indiana for purposes of determining diversity under 28 U.S.C Upon information and believe, at all times relevant and material herein, Defendant Bayer HC is a subsidiary of Defendant Bayer and jointly developed Xarelto with Defendants J&J and Janssen R&D. 9

10 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 10 of 49 PageID Upon information and belief, at all times relevant and material hereto, Defendant Bayer HC was, and is, engaged in the business of designing, researching, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, disseminating and/or selling Xarelto within the State of Florida and throughout the United States. 37. Upon information and belief, at all times relevant and material herein, Defendant Bayer HC has, and does, transact and conduct substantial business in the state of Florida and throughout the United States, as set forth herein, and has, and does, derive substantial revenue from goods and products used in the State of Florida and within the United States. 38. Upon information and belief, Defendant BAYER HEALTHCARE PHARMACEUTICALS INC. (hereinafter referred to as Bayer Pharmaceuticals ), is a corporation organized and existing under the laws of the State of Delaware, with its principle place of business in Montville, New Jersey. 39. Upon information and belief, Defendant Bayer Pharmaceuticals is the U.S. based pharmaceuticals operation of Defendant Bayer HC. As such, Defendant Bayer Pharmaceuticals is a subsidiary of Defendant Bayer. 40. Upon information and belief, at all times relevant and material herein, Defendant Bayer Pharmaceuticals jointly developed, marketed and distributed Xarelto with Defendants J&J and Janssen R&D. 41. Upon information and belief, at all times relevant and material hereto, Defendant Bayer Pharmaceuticals was, and is, engaged in the business of designing, 10

11 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 11 of 49 PageID 78 researching, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, disseminating and/or selling Xarelto within the State of Florida and throughout the United States. 42. Upon information and belief, at all times relevant and material herein, Defendant Bayer Pharmaceuticals has, and does, transact and conduct substantial business in the state of Florida and throughout the United States, as set forth herein, and has, and does, derive substantial revenue from goods and products used in the State of Florida and within the United States. 43. Upon information and belief, Defendant BAYER PHARMA AG f/k/a Bayer Schering Pharma AG (hereinafter referred to as Bayer Pharma ), is a foreign corporation domiciled in Germany with its principle place of business at Mullerstrasse 178, D Berlin, Germany. 44. Upon information and belief, at all times relevant and material hereto, Defendant Bayer Pharma was, and is, engaged in the business of designing, researching, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, disseminating and/or selling Xarelto within the State of Florida and throughout the United States. 45. Upon information and belief, at all times relevant and material hereto, Defendant Bayer Pharma has, and does, transact and conduct substantial business in the state of Florida and throughout the United States, as set forth herein, and has derived substantial revenue from goods and products used in the State of Florida. 11

12 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 12 of 49 PageID Upon information and belief, Defendant BAYER HEALTHCARE AG (hereinafter referred to as Bayer HCAG ) is a foreign corporation domiciled in Germany with its principle place of business at Zentraler Besucherempfang, Kaiser-Wilkhel-Allee D51368, Leverkusen, Germany. 47. Upon information and belief, at all times relevant and material hereto, Defendant Bayer Pharma was, and is, engaged in the business of designing, researching, developing, manufacturing, testing, packaging, promoting, marketing, distributing, labeling, disseminating and/or selling Xarelto within the State of Florida and throughout the United States. 48. Upon information and belief, at all times relevant and material herein, Defendant Bayer HCAG has, and does, transact and conduct substantial business in the state of Florida and throughout the United States, as set forth herein, and has, and does, derive substantial revenue from goods and products used in the State of Florida and within the United States. FACTUAL BACKGROUND 49. At all times relevant and material hereto, the Defendants, directly or by and through their agents, apparent agents, servants or employees designed, researched, developed, manufactured, tested, packaged, promoted, marketed, advertised, labeled, sold and distributed Xarelto, also known as rivaroxaban, as an anticoagulant primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, to treat deep vein thrombosis (hereinafter referred to as DVT ), to treat 12

13 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 13 of 49 PageID 80 pulmonary embolism (hereinafter referred to as PE ), and/or to reduce the risk of recurrence of DVT and/or PE. 50. On or around July 28, 2008, Defendants applied to the Food and Drug Administration (hereinafter referred to as the FDA ), for an initial New Drug Application (hereinafter referred to as NDA ), for Xarelto. 51. On July 1, 2011, the FDA approved Xarelto to reduce the risk of blood clots, DVT and PE following knee and hip replacement surgery On November 4, 2011, Xarelto was approved as an anticoagulant primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation In or around November 2011, Defendants introduced and marketed Xarelto directly to the United States general public and the medical and healthcare community. 54. On November 2, 2012, the FDA expanded the use of Xarelto to the treatment of patients with DVT and PE, as well as long-term treatment to prevent recurrence of the same Xarelto is an anticoagulant that acts as a Factor Xa inhibitor, and is available by prescription in oral tablet doses of 20mg, 15mg, and 10mg. 56. Approval of Xarelto for the prophylaxis of DVT and PE in patients undergoing hip replacement or knee replacement surgeries was based on a series of clinical trials known as the Regulation of Coagulation in Orthopedic Surgery to Prevent Deep 1 NDA ; FDA Reference ID: NDA ; FDA Reference ID: NDA /S-001, /S-002, /S-003; FDA Reference ID

14 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 14 of 49 PageID 81 Venous Thrombosis and Pulmonary Embolism studies (hereinafter referred to as the RECORD studies). 57. The RECORD studies findings showed that rivaroxaban was superior to enoxaparin for thromboprophylaxis after total knee and hip arthroplasty (based on the Defendants definition) and accompanied by similar rates of bleeding However, the RECORD studies also showed a greater incidence with Xarelto of bleeding leading to decreased hemoglobin levels and transfusion of blood Approval of Xarelto for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation in the United States was based on a clinical trial known as the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation study (hereinafter referred to as ROCKET AF ). 60. The ROCKET AF findings showed that rivaroxaban was non-inferior to warfarin for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation, with a similar risk of major bleeding However, bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion. 7 4 Lassen, M.R., et al. Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Total Knee Arthroplasty. N.Engl.J.Med. 2008;358: ; Kakkar, A.K., et al. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet 2008; 372:31-39; Ericksson, B.I., et al. Rivaroxaban versus Enoxaparin for Thromboprophylaxis after Hip Arthroplasty. N.Engl.J.Med. 2008; 358: Id. 6 Patel, M.R., et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N.Engl.J.Med. 2011; 365:

15 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 15 of 49 PageID Approval of Xarelto for the treatment of DVT and/or PE and the reduction in recurrence of DVT and/or PE in the United States was based on the clinical trials known as the EINSTEIN-DVT, EINSTEIN-Extension, and EINSTEIN-PE studies (hereinafter collectively referred to as the ENSTEIN studies). 63. The EINSTEIN-DVT study tested Xarelto versus a placebo, and merely determined that Xarelto offered an option for treatment of DVT, with obvious increased risk of bleeding events as compared to a placebo The EINSTEIN-Extension study confirmed the EISTEIN-DVT results The EINSTEIN-PE study s findings showed that a rivaroxaban regimen was non-inferior to the standard therapy for initial and long-term treatment of PE However, the EINSTEN studies also demonstrated an increased risk of adverse events with Xarelto, including those that resulted in permanent discontinuation of Xarelto or prolonged hospitalization Defendants use the results of the ROCKET AF study, the RECORD studies, and the EINSTEIN studies to promote Xarelto in their promotional materials, including the Xarelto website, which tout the positive results of those studies. However, Defendants promotional materials fail to similarly highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion, among other serious bleeding concerns. 7 Id. 8 The EINSTEIN Investigators. Oral Rivaroxaban for Symptomatic Venous Thromboembolism. N.Engl.J.Med. 2010; 363: ). 9 Roumualdi, E., et al. Oral rivaroxaban after symptomatic venous thromboembolism: the continued treatment study (EINSTEIN-Extension study). Expert Rev. Cardiovasc. Ther. 2011; 9(7): ). 10 The EINSTEIN- PE Investigators. Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism. N.Engl.J.Med. 2012; 366: Id. 15

16 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 16 of 49 PageID Defendants market Xarelto as a new oral anticoagulant treatment alternative to warfarin, a long-established safe treatment for preventing stroke and systemic embolism. Defendants emphasize the supposed benefits of treatment with Xarelto over warfarin, which they refer to as the Xarelto Difference namely, that Xarelto does not require periodic monitoring with blood tests and does not limit a patient s diet. 69. Importantly, there is no antidote to Xarelto, unlike warfarin. Therefore, in the event of hemorrhagic complications, there is no available reversal agent. Xarelto s label does not contain a warning regarding the lack of antidote, but instead only briefly mentions this important fact in the overdosage section. 70. While Defendants enjoy great financial success from their blockbuster drug, Xarelto, they have, and continue to place, unaware and uninformed American consumers at grave risk of suffering fatal, irreversible bleeding and death as a direct result of ingestion of Xarelto. 71. As part of their marketing of Xarelto, Defendants widely disseminated directto-consumer advertising campaigns via print advertisements, online marketing on their website and video advertisements. 72. According to the Defendants direct-to-consumer marketing and informational materials, referenced in the paragraphs below and widely disseminated directly to the consuming public, Defendants negligently represented, and still do, that Xarelto is an easierto-use anticoagulant that requires no medical supervision, is easy for a patient to use and creates the impression that it comes with minimal health risks. 16

17 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 17 of 49 PageID However when warning of safety and risks of Xarelto in marketing and information materials, Defendants have failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of Xarelto, and that such irreversibility of bleeding could have permanently disabling, life-threating and fatal consequences. 74. Defendants have aggressively marketed Xarelto with no regard to the accuracy and repercussions of their misleading advertising in favor of increasing sales. 75. Despite the Defendants aggressive marketing campaign and promotion of Xarelto, Defendants directly ignore patient safety. The Defendants misinformed, and still misinform, consumers and their healthcare providers as to the necessity for routine monitoring of any patient requiring a blood thinning agent. 76. Furthermore, Defendants advertising fails to inform the consumers and their healthcare providers of the fatal risks associated with consumption of Xarelto, in particular, life threatening bleeding and no reversal agent for the bleeding risks. 77. In the January/February 2013 issue of WebMD magazine, Defendants marketing and information materials to the general public resulted in the Office of Prescription Drug Promotion of the FDA sending a letter stating that their print advertisement was false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim. Furthermore, the advertisement states And there are no dosage adjustments (emphasis original) in direct conflict with the product labeling approved by the FDA. 17

18 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 18 of 49 PageID 85 - January/February 2013 issue of WebMD magazine 78. Moreover, Defendants fail to adequately warn consumers and the medical and healthcare community about the lack of antidote to reverse uncontrolled bleeding caused by Xarelto. Instead, Defendants merely indicated, and still indicate, that there is a risk for bleeding but side-step the critically important issue of how to reverse the effects of Xarelto should a life-threatening bleed occur. 18

19 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 19 of 49 PageID Specifically throughout Xarelto s website targeting consumers, Defendant sparingly mentions the risk for bleeding under the title WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO by merely stating that Xarelto can cause bleeding, which can be serious, and rarely may lead to death. This is because Xarelto is a blood thinner medicine that reduces blood clotting. (emphasis original) Importantly, Xarelto s consumer-targeted website does not warn of the irreversible nature of Xarelto nor does it adequately inform consumers about the risks of uncontrollable bleeds and that there are safer blood thinning alternatives available with existing antidotes that can reverse uncontrollable bleeding. 81. Defendants physician-targeted website also fails to adequately warn of Xarelto s bleeding risks, the lack of an antidote or otherwise advise the medical and healthcare community on how to intervene a stabilize a patient a should a life-threatening bleed occur. 82. Furthermore, Xarelto s black box warning did not address the increased risk for serious and fatal bleeding and lack of antidote, and in fact, even though a label change occurred in March 2014, as of today, Xarelto still does not have a black box warning informing patients or prescribing doctors that Xarelto can cause irreversible bleeds. 83. Accordingly, Defendants labeling, marketing and promotional information for Xarelto: 12 https://www.xarelto-us.com/ (January 19, 2015) 19

20 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 20 of 49 PageID 87 (a) Fails to investigate, research, study and define, fully and adequately, the safety profile of Xarelto; (b) Fails to provide adequate warnings about the true safety risks associated with the use of Xarelto; (c) Fails to disclose in the Warnings Section that there is no drug, agent or means to reverse the anticoagulation effects of Xarelto and that if serious bleeding occurs, such irreversibility could have permanently disabling, life-threating or fatal consequences; (d) Fails to advise prescribing physicians, such as the Plaintiff s physician, to instruct patients that there was no agent to reverse the anticoagulant effects of Xarelto; (e) Fails to provide adequate instructions on how to intervene and/or stabilize a patient who suffers a bleed while taking Xarelto; (f) Fails to provide adequate warnings and information related to the increased risks of bleeding events associated with aging patient populations of Xarelto users; (g) Fails to provide adequate warnings regarding the increased risk of suffering a serious bleeding event, requiring blood transfusions in those taking Xarelto; and (h) Fails to include a black box warning about serious bleeding events associated with Xarelto. 20

21 Case 8:15-cv VMC-EAJ Document 8 Filed 01/27/15 Page 21 of 49 PageID Moreover, Defendants marketing and information materials negligently and improperly fail to highlight the risks of serious bleeding events that were demonstrated in Xarelto s three medical studies, but instead, aggressively market the limited studies positive results and promote Xarelto to the general public and medical and healthcare community as superior to warfarin without adequately warning of the life-threatening bleeds and lack of a reversal agent to the medications blood thinning effects. 85. With the knowledge of the relationship between Xarelto and irreversible, lifethreatening bleeds, Defendants have, and continue to, aggressively promote and market Xarelto as a safe and effective treatment rather than taking steps to pull the drug off the market, provide stronger and effective warnings, and/or create an antidote to reverse the bleeding risks. 86. Significantly, in the first quarter of 2012, The Institute for Safe Medication Practices (hereinafter referred to as the ISMP ), identified 356 reports of serious, disabling, or fatal injury in which rivaroxaban was the primary suspect drug. The report more than doubled from the previous quarter total of 128 cases. The ISMP referred to these figures as a strong signal regarding the safety of Xarelto, which as defined by ISMP is evidence of sufficient weight to justify an alert to the public and the scientific community, and to warrant further investigation. 87. However when ISMP discussed the findings with Defendants, the [Defendants] told [ISMP] that it had reviewed the same data and saw no signal of a safety issue that needed to be addressed Institute for Safe Medication Practices, QuarterWatch Report, Monitoring FDA MedWatch Reports Why 21

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